Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Accelerating Vaccine Production Using a Nonviral Enabling Technology for Cell Engineering

At the recent World Vaccine Conference, Victor Ayala, PhD, an early stage investigator with Advanced BioScience Laboratories, Inc. (ABL), discussed how to accelerate vaccine production using a nonviral enabling technology for cell engineering. ABL is a contract research/manufacturing organization (CRO/CMO) providing manufacturing and laboratory research services to advance leading vaccines and therapies from clinical development to the commercial market. The company has been conducting R&D research for over 55 years and performing CMO manufacturing for over 25 years. With more than 200 employees worldwide, ABL has sites in Rockville, MD, as well as Strasbourg and Lyon, France. Services include preclinical and clinical immunobiology services, product development, and biomanufacturing. The following are highlights of Dr. Ayala’s presentation.

When it comes to protein expression, manufacturers have a choice among a range of technologies for implementation. However, such systems all fall into one of two basic categories: stable cell lines or transient transfection. Industry and regulatory agencies prefer stable cell lines because they provide product consistency. They are well-characterized systems, and the source of production is indefinite. But using stable cell lines can be expensive and time consuming. Researchers want to fire off as many candidate biologics as possible, especially in early phases of discovery or development. If that process is so burdened that it becomes inhibitory to execute, it slows the development train and ultimately increases the medical costs associated with preventable diseases.

An alternative method is to use transient transfection, which can be low-cost and high-yielding. One major advantage to using this approach over generating a cell line is that it elminiates the need for generating a master cell-bank (MCB) every time you want to manufacture a drug molecule. Shortcomings of using transient transfection include a finite production of proteins, inefficiencies with Chinese hamster ovary (CHO)cells (the cell line preferred by industry for antibodies and recombinant glycoproteins such as HIV envelopes), and concerns about product variability.

The MaxCyte flow electroporation technology has been a breakthrough technology for ABL in many areas of research. We have been working with MaxCyte for over five years and currently use the STX and VLX systems in process development (PD) and manufacturing. ABL recently purchased an additional STX unit for R&D work to bridge the gap between product innovation and PD.